| Trial ID: | L6075 |
| Source ID: | NCT01798238
|
| Associated Drug: |
Mp-513
|
| Title: |
Teneligliptin(MP-513) Versus Placebo in Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: MP-513|DRUG: Placebo
|
| Outcome Measures: |
Primary: Glycosylated hemoglobin, Visit 1(Baseline Visit) vs Visit 7(week 24) | Secondary: Mean fasting plasma glucose, Visit 1(Baseline Visit) vs Visit 7(week 24)|Weight, Visit 1(Baseline Visit) vs Visit 7(week 24)|Glycosylated hemoglobin <7.0% subject percent, Visit 1(Baseline Visit) vs Visit 7(week 24)|Triglycerides, Visit 1(Baseline Visit) vs Visit 7(week 24)|Homeostatic model assessment of insulin Resistance, Visit 1(Baseline Visit) vs Visit 7(week 24)|Body mass index, Visit 1(Baseline Visit) vs Visit 7(week 24)|Low Density Lipoprotein, Visit 1(Baseline Visit) vs Visit 7(week 24)|High Density Lipoprotein, Visit 1(Baseline Visit) vs Visit 7(week 24)|Cholesterol, Visit 1(Baseline Visit) vs Visit 7(week 24)|Connecting peptide, Visit 1(Baseline Visit) vs Visit 7(week 24)|Insulin, Visit 1(Baseline Visit) vs Visit 7(week 24)|Homeostatic model assessment of beta-cell function, Visit 1(Baseline Visit) vs Visit 7(week 24)|Glycosylated hemoglobin <6.5% subject percent, Visit 1(Baseline Visit) vs Visit 7(week 24)
|
| Sponsor/Collaborators: |
Sponsor: Handok Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
142
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-11
|
| Completion Date: |
2014-05
|
| Results First Posted: |
|
| Last Update Posted: |
2014-08-05
|
| Locations: |
Handok INC, Seoul, Gangnam-Gu, Korea, Republic of|Handok Pharmaceuticals CO. LTD, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01798238
|
